Cardiovascular Disease
Conditions
Keywords
Cardiopulmonary Bypass, Aortic Valve Repair, Coronary Re-Implantation, Deep Hypothermic Circulatory Arrest, Factor VIII Inhibitor Bypass Activity, Transfusion
Brief summary
The purpose of this pilot study is to evaluate the feasibility of the prophylactic administration of Factor VIII Inhibitor Bypass Activity (FEIBA) at termination of cardiopulmonary bypass (CPB) period. Specifically, the proposed study is designed to demonstrate the potential role of FEIBA administration in reducing the need for allogeneic transfusion to treat refractory coagulopathy in high risk patients.
Detailed description
Factor eight inhibitor bypassing activity (FEIBA) is currently approved for use in this country for the treatment of patients with Hemophilia and inhibitors at a dose of 50-100 units/kg. There is a large body of evidence demonstrating the safety and efficacy of FEIBA for Hemophilia patients with inhibitor and has a theoretical advantage compared to current blood product transfusion methods, as it replenishes multiple depleted factors that are lost with prolonged exposure to CPB. This pilot study is a single center, randomized, double-blinded, placebo controlled trial assessing the feasibility and safety of factor eight inhibitor bypass activity (FEIBA) in patients undergoing major cardiovascular surgery requiring prolonged CPB. The study population will consist of adult patients undergoing elective cardiac surgery at OHSU. Twelve participants will randomly assigned to receive FEIBA or placebo during their surgical procedure. Patients will be followed to review for adverse events while in the ICU, and up to four weeks after discharge.
Interventions
DRUGFEIBA
Administration of FEIBA after cardiopulmonary bypass
DRUGNormal Saline
Administration of placebo after cardiopulmonary bypass
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Elective aortic or aortic valve procedures, coronary re-implantation (Bentall) with cardiopulmonary bypass, and/or deep hypothermic circulatory arrest. * Written informed consent
Exclusion criteria
* Contraindications to the administration of FIEBA or known anaphylactic or severe hypersensitivity reactions to FEIBA or any of its components * Disseminated intravascular coagulation (DIC) * Acute thrombosis or embolism, including myocardial infarction * Pregnant women * Decisionally impaired adults * Prisoners * Expressed unwillingness or are otherwise deemed unable to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of blood products transfused (mL) | 30 days | -Cumulative volume of blood products transfused, defined as the volume in mL of packed red blood cells, fresh frozen plasma, and platelets, after the administration of the study drug (mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of thrombotic or thromboembolic events | 30 days | \- thrombotic or thromboembolic events are defined as any event of deep venous thrombosis, pulmonary embolism, stroke, or MI |
| Number of patients with post-operative bleeding requiring surgical hemostasis | 30 days | — |
| Duration of post-operative ventilation, ICU and hospital length of stay | 30 days | — |
| Number of deaths | 30 days | — |
Countries
United States
Outcome results
None listed